Not yet recruitingOBSERVATIONAL

Power of Liquid Biopsy Tracking in Immunotherapy Treated Stage IV Melanoma

After successful immunotherapy for advanced melanoma, patients currently have many scans over several years. This study wants to find out if using simple blood and urine tests, called 'liquid biopsies', can detect cancer returning just as well, or even better, than these frequent scans. This could mean fewer hospital visits and less radiation exposure for patients. We're exploring different ways to analyse these samples, including looking for tiny bits of cancer DNA and also examining how the immune system reacts. The aim is to make follow-up care easier and more accurate for people who have had melanoma.

At a glance

Status

Not yet recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

100

Start

01 Feb 2025

Estimated completion

01 Jan 2029

Metastatic Melanoma

What is this study about?

If you've had advanced melanoma and received immunotherapy, you’ll know that follow-up often involves many scans over a long period. While these scans are important, they expose you to radiation and can be quite time-consuming. This study is exploring a new way to monitor your health that might be simpler and less demanding.

The main idea is to use "liquid biopsies" – which means looking for clues about the cancer in blood and urine samples. We're trying to see if these simple tests can reliably detect if the melanoma is coming back or getting worse at the same time as, or even before, current scans would show it. This could potentially reduce the number of scans you need in the future. We're testing different methods, looking for tiny fragments of cancer DNA in the blood and even studying urine to see if it can help detect if the cancer has returned in difficult-to-find areas like the brain.

Beyond just looking at cancer DNA, we're also investigating how your immune system responds. We believe that if the cancer does start to return, your body's immune system might show certain changes. By teaming up with experts in immune system analysis, we hope to find new ways to spot these changes early. This could be especially helpful for people whose cancer doesn't release much DNA into their blood, making it harder to detect with standard liquid biopsies.

Key takeaways

Exploring new, less invasive ways to monitor melanoma.
Using simple blood and urine tests instead of frequent scans.
Aims to reduce radiation exposure and hospital visits for patients.
Also investigating how the immune system responds to cancer returning.
Your standard medical care will not be affected by participating.
Your contribution helps research for future melanoma patients.

Who may be eligible?

This study is looking for people who currently have, or have had, advanced melanoma that has spread (stage III or IV). You must have received at least one cycle of immunotherapy for your melanoma. Importantly, your latest scans need to show that your melanoma has started to get worse or has come back within the last month.

You must be aged 16 years or older. You should be receiving standard follow-up care, which includes regular scans. You should not have been previously diagnosed with HIV, Hepatitis B, or C. The study team will not test you for these conditions, they will just ask about your medical history.

There are also some reasons why you might not be able to join. For example, if you're not having regular scans as part of your usual care, or if you have another ongoing cancer that needs treatment. Also, if there are medical reasons or conditions that would make it difficult for you to understand what's involved in the study or to provide the samples as requested, you might not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have advanced melanoma (stage III or IV).
I have had immunotherapy for my melanoma.
My recent scan showed that my melanoma has started to get worse or come back.
I am aged 16 or over.
I am having regular scans as part of my routine follow-up care.
I do not have HIV, Hepatitis B, or C.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide some simple samples. This will include a blood sample, taken using a small needle, and a dried blood spot which involves placing a few drops of blood onto a special card. We will also ask for a urine sample. These samples will be collected when your scans show that your melanoma has started to progress (get worse or come back).

There are no extra hospital visits specifically for this study beyond your regular appointments for scans and follow-up care. You will continue to receive your standard medical treatment and check-ups as planned by your medical team. The study itself doesn't involve any new medications or treatments; it's focused on collecting and analysing these extra samples to learn more about new detection methods. The total duration of your participation would be centred around the time of your disease progression detection.

Potential risks and benefits

Taking part in this study won't change your medical treatment or follow-up care, so there are no direct medical risks from the study itself beyond the minor discomfort of blood draws. However, the information we gain could help design better, less intrusive ways to monitor melanoma in the future, benefiting other patients. This is a pilot study, so we don't expect it to directly benefit you at this stage, but your contribution is vital for future research. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Royal Marsden
Verified postcode
Chelsea, United Kingdom

Common questions

What is 'liquid biopsy'?

Liquid biopsy is a simple test using a blood or other body fluid sample (like urine) to look for tiny pieces of cancer cells or their DNA, instead of needing a tissue sample from a biopsy.

Will this study change my melanoma treatment?

No, this study is about finding new ways to monitor melanoma progression, not to change your current treatment plan. You will continue to receive your standard care.

Why are you looking at urine samples?

We are looking at urine samples because sometimes it can be harder to detect cancer returning in certain areas, like the brain, using only blood samples. Urine might give us different clues.

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight the cancer more effectively.

What if I decide I don't want to participate anymore?

You can leave the study at any time without giving a reason. Your decision will not affect your current or future medical care.

How to find out more

Arjun Modi, MSc

arjun.modi@rmh.nhs.uk 020 7352 8171 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.